Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation (QuitWIT)
Kidney Transplant; Complications, Delayed Graft Function
About this trial
This is an interventional device feasibility trial for Kidney Transplant; Complications focused on measuring kidney, transplant, warm ischemia time, delayed graft function, vascular anastomosis, renal hypothermia
Eligibility Criteria
Inclusion Criteria:
- ≥18 years of age at time of transplant
- Slated to receive a single cadaveric organ
- Donor declared by traditional neurological determination of death (NDD)
- Standard criteria donor (SCD) or Extended criteria donor (ECD)
- Consent obtained prior to the transplant operation
Exclusion Criteria:
- Living donor (LD)
- Donor after cardiocirculatory death (DCD)
- Highly sensitized patients (those with Panel-reactive antibody or PRA >80%)
- Recipient of a previous kidney transplant
Sites / Locations
- Queen Elizabeth II Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Surgery utilizing the Kidney Skinn cooling device
Standard transplant surgery practice
All patients in Part A, and those randomized to the Kidney Skinn arm in Part B, will receive transplant surgery in the traditional fashion with the exception that the renal allograft will be placed in the cooling device at the initiation of the vascular anastomosis. Cold saline irrigation flowing through the device will be used to maintain renal hypothermia for the duration for the vascular anastomosis. After the vascular clamps are released, the device will be removed.
Standard transplant surgery per site practice